Never Again: Preventing Future IRAs on Behalf of Patients

The path a drug travels before it reaches a patient’s bedside is paved with regulatory and scientific review processes in order to ensure its safety and effectiveness for users. Not only does the Food and Drug Administration (FDA) have benefit-risk assessments in place to review drugs before they reach the market, but the agency is also accountable for recalling or issuing safety alerts if a product poses safety concerns.

If our medicines and the government body overseeing their availability is held to these rigorous review processes and standards, then why aren’t Congress’s policy prescription, too?

Case and point: The disastrous Medicare Drug Price Negotiations was passed without any regard for the impact such legislation would have on patients and their reliance on cutting-edge medical innovation. These “negotiations” were a coercive tactic by progressive politicians to force egregiously low prices onto manufacturers, cutting research and development spending. As a result, access to new lifesaving treatments and cures for millions of American patients who are living with life-threatening, chronic, or rare diseases will shutter to a halt. It is obvious that lawmakers did not do their due diligence on how devastating these policies will be to patients. To prevent such a catastrophe from happening again, Survivors for Solutions has put forth two policy suggestions – the Patient PACT Act and Rx MIRACLE Act – that would ensure accountability measures are in place to guarantee patients don’t become victims of poorly advised policies.

With Congress cluelessly passing drug pricing legislation without timely, objective, peer-reviewed, nonpartisan information on how they would impact the discovery of cures, they are signaling to patients that protecting their access to high-quality healthcare isn’t a priority. To address this serious problem, the Patient Access to Cures & Treatments Act (Patient PACT Act) would guarantee that new policies impacting chronic or rare disease patients are properly examined through nonpartisan review boards to confirm they don’t reduce important research and development funding that directly saves patient lives.

Another issue plaguing the passage of healthcare legislation is that the policies are often judged and decided by the party in power, leading to politics outranking patient health. With thousands of lives at stake, the Rx Medical Innovation Review & Accessibility Council on Legislative Efficacy Act (Rx MIRACLE Act) would ensure that patients are not the ones to pay for party politics. This bill would require the Department of Health and Human Services (HHS) to establish an annual review of the regulatory impact of new legislation to examine its side effects, such as potential drug shortages or reduction in R&D investments for treatments relied on by chronic and rare disease patients. Importantly, while HHS would set broad guidelines, the actual review would be conducted by an organization that isn’t politically affiliated. The bill would also require any major changes affecting innovation to be sunsetted after five years, with congressional renewal also required.

Raw data and accountability measures are our best bet at ensuring congressional power is checked. The medical innovation ecosystem is too delicate to tamper with using untried, unproven policies. There are real lives that are impacted by drug pricing policy, and Congress must be held accountable for any solutions they pass. If implemented, these bills would be the first step in the right direction to keeping current and future patients safe from shortsighted lawmakers who will pass anything that looks good on paper with no regard for the potential long-term impacts.